Cervical collar with reduced vascular obstruction

ABSTRACT

A cervical collar has an anterior portion and a posterior portion having side extending portions removably connecting to the anterior portion. The posterior portion includes a rigid or semi-rigid main support piece and a resilient edge integrally secured to at least a substantial portion of a periphery of the main support piece that is substantially more flexible than the main support piece. The main support piece defines opposed upper side sections and a lower section. The upper side sections extend upwardly from the side extending portions and are oriented toward a proximal middle region and spaced apart by a first distance. The lower section extends continuously between the side extending portions and is spaced a second distance from the upper side sections.

This application is a continuation of prior application Ser. No.12/729,536, filed Mar. 23, 2010, which is a continuation-in-part ofprior application Ser. No. 12/629,197, filed Dec. 2, 2009, now U.S. Pat.No. 7,981,068, granted Jul. 19, 2011, which application claims thebenefit of U.S. Provisional Application No. 61/119,425, filed Dec. 3,2008, and U.S. Provisional Application No. 61/241,528, filed Sep. 11,2009, which applications are hereby incorporated by reference herein intheir entirety, inclusive of their specifications, claims, and drawings.

FIELD OF THE INVENTION

The invention relates generally to the field of orthopedic or prostheticdevices and more specifically to cervical collars having reducedvascular obstruction.

BACKGROUND

Cervical collars are used in the treatment, stabilization,immobilization, and therapy of cervical trauma. Since cervical spinalinjuries are often accompanied by severe head trauma, the first responseis often to immobilize the neck (columna cervicalis; cervicalvertebral/spinal column). For example, some collars are intended toprovide support for whiplash and other such injuries where support forthe head and neck is needed. Other collars are intended for nearcomplete immobilization of the head and neck, such as in an EMS(Emergency Medical Services) pre-hospital setting. The immobilization isdone to prevent further damage in waiting for subsequent surgicaloperation or treatment; sometimes, however, the immobilization is usedas a final treatment of spinal injuries.

In such an EMS pre-hospital setting, which typically involves vehicularaccident victims or others who have suffered head trauma, victims arealso at a substantial risk of having a cervical spine injury (“Effect ofcervical hard collar on intracranial pressure after head injury,” ANZ JSurg 2002 June; 56(6):511-3; Mobbs et al.). In such cases, a rigidcervical collar can be applied until it is determined that there is nounderlying cervical spine injury (id.).

Thus, it is recognized that spinal immobilization can be achieved by theapplication of a rigid collar to protect the neck and forms an integralpart of care of the injured. However, patients with combined head andneck injuries often have higher intracranial pressure (ICP) that may becaused by intracranial hemorrhage and or contusion of the brain.

Intracranial pressure is a dangerous condition, and a number of studieshave shown that the use of rigid cervical collars can actually raiseintracranial pressure. In particular, the very nature of rigid cervicalcollar designs predisposes to vascular obstruction of blood drainingfrom the brain, which theoretically may lead to an increase inintracranial pressure.

In fact, some current types of rigid cervical collars are known toprovide an increase in pressure on neck veins (vena jugularis externaand interna; external and internal jugular veins) thereby causing stasisin the veins and leading to an increase intracranial pressure. Anincrease in intracranial pressure deceases cerebral perfusion andexacerbates ischemia, and thus can lead to an increase in the chancesfor a secondary brain injury can occur (“The effect of rigid cervicalcollars on internal jugular vein dimensions,” Acad Emerg Med; January2010, Vol. 17, No. 100-102; Stone et al.).

This suggests that in patients having head injuries, when a rigid collaris used to stabilize the cervical spinal column, the rigid collar shouldbe removed as soon as cervical spine injury has been ruled out.

There is an apparent need then for a short and long term use cervicalcollar that does not obstruct the blood drain from the brain.

SUMMARY

An embodiment of a cervical collar according to the present disclosureprovides sufficient stabilization and immobilization of the cervicalspinal column, while at the same time having reduced vascularobstruction. In particular, an embodiment of a cervical collar accordingto the present disclosure has less contact with, and produces lesspressure on, the sternocleidomasteoidus (sternomastoid muscle) area ofthe neck and is thus less likely to cause pressure on the veins in theneck. This may decrease the possibility of vascular obstruction of blooddraining from the brain and thus, the cervical collar according to thepresent disclosure is less likely to increase intracranial pressure.

Specifically, the shape of the cervical collar at the anterior portion,when applied to the neck of a patient, defines a clearance of the neckveins by way of fold lines formed along the anterior portion of thecollar. In an exemplary embodiment, the fold lines can be formed byutilizing a living-hinge structure for each fold line.

The fold lines are provided along a posterior surface of the anteriorcervical collar portion. The fold lines are generally arrangedperpendicularly on either side of an open access area defined along theanterior cervical collar portion. The fold lines allow the generallyrigid plastic of the cervical collar to naturally curve into a shapethat provides the appropriate clearance for the neck veins.

The central portion of the anterior portion of the cervical collarattaches to the sternal extension adjustment part, and is relativelyflat, while the curve of the anterior portion of the cervical collarprovided by the fold lines forms a generally rounded corner leaving agap opposite to the relatively curved surface of the neck at thelocation of the large cervical veins (vena jugularis externa andinterna; external and internal jugular veins) draining blood from thebrain, thus, providing reduced vascular obstruction, and reducing thelikelihood of an increase in intracranial pressure.

The fold lines providing the reduced vascular obstruction for thecervical collar can be implemented in a cervical collar having heightand circumferential adjustment, in order to accommodate a wide varietyof sizes of different patients and to accommodate size changes caused byincreased or decreased swelling of the affected anatomical portions ofthe patients. However, the fold lines can be provided to any cervicalcollar configuration, adjustable in size or not.

Additional features of the cervical collar can include a removablesternal adjustable height support piece to allow the collar to beadjusted or removed, for example for cleaning or to check for pressuresores, without removing life support attachments such as breathing andfeeding tubes.

Flexible or compliant edges and anatomically shaped portions on thecervical collar can be provided to accommodate different sized users, toaccommodate changes in anatomical shape due to an increase or decreasein swelling, and to prevent pressure peaks, even if the collar isimproperly applied to the patient.

The disclosed cervical collar is configured to conform to the anatomy ofthe patient, and to be a generally constant contact collar that contactsthe skin of the patient. With this in mind, the collar allows someamount of patient movement, permitting the collar to move with thepatient while still providing clearance with, and producing lesspressure on, the sternomastoid muscle area of the neck. This arrangementmakes it less likely that the collar provides pressure on the veinsalong the neck.

The combination of flexible or compliant edges and anatomically shapedportions on the cervical collar along with ventilation mechanisms, suchas ventilation slots, allow the collar to have intimate contact with theskin of the patient (with or without the use of a liner).

In a variation of the aforementioned embodiments, a foam cervical collarincludes recessed or cutout surfaces that provide a gap between thecervical collar and the neck, thus providing clearance with, andproducing less pressure on, the sternomastoid muscle area of the neckmaking the collar less likely to form pressure on the veins along theneck.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features, aspects, and advantages of the presentinvention will become better understood with regard to the followingdescription, appended claims, and accompanying drawings where:

FIG. 1 is a front view of an anterior portion of a cervical collar inaccordance with the present disclosure;

FIG. 2 is a front view of the anterior portion of the cervical collarshown in FIG. 1 with the height adjustment piece removed for the sake ofclarity;

FIG. 3 is a perspective view of the anterior portion of the cervicalcollar shown in FIG. 1 with the height adjustment piece separatedtherefrom for the sake of clarity;

FIG. 4 is a rear view of the anterior portion of the cervical collarshown in FIG. 1;

FIGS. 5 and 6 are respectively a side perspective and rear perspectiveview of the locking button of the height adjustment piece of thecervical collar shown in FIG. 1;

FIG. 7 is a front view of a posterior portion of a cervical collar inaccordance with the present disclosure;

FIG. 8 is a perspective view of the posterior portion of the cervicalcollar shown in FIG. 7;

FIG. 9 is a rear view of the posterior portion of the cervical collarshown in FIG. 7;

FIGS. 10 and 11 are respectively a front side perspective and rearperspective view of the anterior and posterior portions of the cervicalcollar together in use on a patient;

FIG. 12A is a simplified side view of the muscular structure of theneck;

FIG. 12B is a simplified rear view of the muscular structure of theneck;

FIG. 13 is a perspective view of the anterior and posterior portions ofthe cervical collar together in use on a patient exemplifying theclearance or gap between the cervical collar and the sternomastoidmuscle area of the neck;

FIG. 14 is a simplified cross-sectional view of the anterior andposterior portions of the cervical collar together in use on a patientand showing the gap formed at the sternomastoid muscle area of the neckso as to be less likely to form pressure on the veins along the neck;

FIG. 15 is a perspective view of an anterior portion of a variation of acervical collar having reduced vascular obstruction;

FIG. 16 is a top view of the anterior portion of the cervical collar asshown in FIG. 15, and also generally showing a cross-section of theneck; and

FIG. 17 is a rear view of the anterior portion of the cervical collar asshown in FIG. 15.

It should be noted that the drawing figures are not necessarily drawn toscale, but instead are drawn to provide a better understanding of thecomponents thereof, and are not intended to be limiting in scope, butrather to provide exemplary illustrations. It should further be notedthat the figures illustrate exemplary embodiments of a cervical collarhaving reduced vascular obstruction and the components thereof, and inno way limit the structures or configurations of a cervical collarhaving reduced vascular obstruction and components thereof according tothe present disclosure.

DETAILED DESCRIPTION

A. Environment and Context

Embodiments of an orthopedic device are provided for use in stabilizingand supporting anatomical portions of a patient, for example, the neckand head of a patient.

Although the embodiments of the disclosure are adapted for supportingand stabilizing anatomical portions of a large number of patients havingvarious anatomical shapes and sizes, the embodiments of the disclosuremay also be dimensioned to accommodate different types, shapes and sizesof anatomical portions.

Exemplary materials and configurations for components of the orthopedicdevice, such as the structural supports or shells and flexible orcompliant portions, as well as exemplary uses and connection mechanismsare described in detail in U.S. Pat. No. 5,180,361, granted January1993, U.S. Pat. No. 5,445,602, granted August 1995, U.S. Pat. No.5,622,529, granted April 1997, U.S. Pat. No. 5,632,722, granted May1997, U.S. Pat. No. 5,716,335, granted February 1998, U.S. Pat. No.6,071,255, granted June 2000, U.S. Pat. No. 6,254,560, granted July2001, U.S. Pat. No. 6,663,581, granted December 2003, U.S. Pat. No.7,018,351, granted March 2006, and U.S. Pat. No. 7,198,610, grantedApril 2007, and all incorporated herein in the entirety by reference.

For ease of understanding the disclosed embodiments of an orthopedicdevice, the anterior and posterior portions of the orthopedic device aredescribed independently. It will be recognized that the anterior andposterior portions of the orthopedic device function together to form asupporting and stabilizing collar that encompasses the anatomicalportions of the wearer.

For further ease of understanding the embodiments of an orthopedicdevice as disclosed herein, a description of a few terms is necessary.As used herein, the term “proximal” has its ordinary meaning and refersto a location situated next to or near the point of attachment or originor a central point, or located toward the center of the body. Likewise,the term “distal” has its ordinary meaning and refers to a location thatis situated away from the point of attachment or origin or a centralpoint, or located away from the center of the body. The term “posterior”also has its ordinary meaning and refers to a location that is behind orto the rear of another location. Lastly, the term “anterior” has itsordinary meaning and refers to a location that is ahead of or to thefront of another location.

The terms “rigid,” “flexible,” “compliant,” and “resilient” may be usedherein to distinguish characteristics of portions of certain features ofthe orthopedic device. The term “rigid” is intended to denote that anelement of the device is generally devoid of flexibility. Within thecontext of support members or shells that are “rigid,” it is intended toindicate that they do not lose their overall shape when force isapplied, and in fact they may break if bent with sufficient force. Onthe other hand, the term “flexible” is intended to denote that featuresare capable of repeated bending such that the features may be bent intoretained shapes or the features do not retain a general shape, butcontinuously deform when force is applied. The term “compliant” is usedto qualify such flexible features as generally conforming to the shapeof another object when placed in contact therewith, via any suitablenatural or applied forces, such as gravitational forces, or forcesapplied by external mechanisms, for example, strap mechanisms. The term“resilient” is used to qualify such flexible features as generallyreturning to an initial general shape without permanent deformation. Asfor the term “semi-rigid,” this term is used to connote properties ofsupport members or shells that provide support and are free-standing,however such support members or shells may have some degree offlexibility or resiliency.

B. Detailed Description of an Anterior Portion of an Orthopedic Device

An anterior portion 100 of an orthopedic device, such as a cervicalcollar, is shown in FIGS. 1-4. The anterior portion 100 generallyincludes three components.

The first component is a main support piece 102. The main support piece102 has the form of a rigid or semi-rigid shell that is formed slightlyout of plane to extend towards first and second sides. The main supportpiece 102 includes a plurality of spaced substantially verticallyoriented or angled arcuate slots 104 that aid with ventilation of theorthopedic device in use, and also provide additional resiliency toallow the main support piece 102 to be bent to conform to the anatomicalportion of the user, such as the neck.

The main support piece 102 also includes two spaced dependingprojections 106 that define an open access area 108 therebetween toallow access to, for example, the trachea of a wearer.

A thickened support section 110 runs along the main support piece 102from a first end of a first depending projection 106 in a generallyU-shape along the main support piece 102 to a first end of a seconddepending projection 106. The thickened support section 110 providesadditional support for the main support piece 102 and for the adjustableheight support 130 discussed in detail below. As an alternative, a rodor stay that is flexible, such as an aluminum rod, can be integratedinto the main support piece 102 in place of the thickened supportsection 110.

In addition to the thickened support section 110, a supporting springportion 112 is formed, for example, to support the chin of patient. Thesupporting spring portion 112 provides a stable but dampening supportunder the chin of the patient, and restricts flexion. The use of thesupporting spring portion 112 in combination with a flexible edge(discussed in more detail below) also aids with reducing or eliminatingpressure points.

Ribs 113 are formed below the spring 112 to provide connection pointsfor an attachment piece (chin strut) used to connect a chest plate(forming part of a thoracic extension) to the cervical collar. Anexemplary thoracic extension is described in detail in U.S. Pat. No.6,921,376, granted Jul. 26, 2005, and herein incorporated in theentirety by reference.

Height adjustment indicia 114 are provided on the depending projectionsto provide easy sizing of the cervical collar using predetermined sizes,such as small, medium, large, etc. The height adjustment indicia 114 canbe in the form of standardized, color coded markings and/or lines thatreflect standardized marking systems used to indicate patient sizes.Other indicia, such as alphanumeric labels, can also be used. The heightadjustment indicia 114 cooperate with leading edges of the adjustableheight support 130 to provide an indication of the current sizing of thecervical collar.

As seen in FIG. 4, a plurality of locking projections, or ratchets, 116are formed along each of the depending projections 106 in a linearfashion to cooperate with the adjustable height support 130 discussed indetail below. The locking projections 116 can have a rounded first edgehaving a first thickness that tapers out to a linear edged having asecond thickness that is larger than the first thickness, wherein thelinear edge is configured to engage with associated teeth 136 positionedon the adjustable height support 130, as discussed below.

As also shown in FIG. 4, the posterior side of the main support piece102 includes liner connection points 128, where a suitable removableliner, such as a disposable hydrophilic foam pad liner, can be connectedto the cervical collar. The connection points 128 can be formed as hookmembers, integrally formed on the main support piece 102, for example,by injection molding, and configured to cooperate with loops formed onthe liner or attached to the liner. Alternative connection mechanisms,such as hook and loop fasteners applied by adhesive or snap fasteners,can also be used. The use of the integrally formed hooks for theconnection points 128 eliminates sharp or rough edges associated withthe use of plastic rivets to connect a liner to an orthopedic device,thus providing a more comfortable fit with a reduced chance of pressuresores developing.

The main support piece 102 includes resilient or flexible edges 118formed along the periphery of the main support piece 102, for example,by overmolding a resilient or compliant material thereon. The use offlexible edges 118 allows the cervical collar to distribute pressurepeaks over larger areas in order to avoid the formation of pressureulcers. The flexible edges 118 can also prevent pressure peaks even whenthe collar is improperly applied.

The flexible edges 118 can be integrally formed with the secondcomponent of the anterior portion 100 of the orthopedic device, athree-dimensional (3D) anatomically configured proximal support portion120. The 3D anatomically configured proximal support portion 120 canalso be formed as a resilient or flexible overmolded portion. The 3Danatomically configured proximal support portion 120 includes ananatomical, generally cup-shaped portion 122 configured to support, forexample, the chin of a wearer.

As best seen in FIGS. 3 and 4, the 3D anatomically configured proximalsupport portion 120 is formed around and encompasses the supportingspring portion 112.

Orienting indicia 124, such as arrows and/or words indicating thedirections that the anterior main support piece 102 is to be applied tothe wearer, can be formed directly in the 3D anatomically configuredproximal support portion 120 and also on the main support piece 102. Itwill be recognized that orienting indicia 124 may take any suitableshape or form and can be positioned on any of the components of theorthopedic device.

As best seen in FIG. 4, fold lines 125, 126 are formed in each of themain support piece 102, the flexible edges 118, and the 3D anatomicallyconfigured proximal support portion 120. The fold lines 125, 126 may becreated, for example, via a living hinge, which is a reduced thicknessportion provided between two adjacent portions having a largerthickness. Alternatively, the fold lines 125, 126 may be formed byproviding a resilient or compliant interface, such as by overmolding,between the portions that are to be folded over. As shown, the foldlines 125 positioned closer to the center line of the anterior portion100 may be substantially straight, to allow for a sharp fold, while thefold lines 126 positioned closer to the edges of the anterior portion100 may be arcuate shaped, to allow for more gradual folds. The foldlines 125, 126 allow the anterior portion 100 to be bent or folded toaccommodate different circumferences of anatomical portions. In theexemplary embodiment shown, four fold lines 125 are provided on eitherside of the access opening 108, however, it will be recognized the moreor fewer fold lines may be provided.

In use, the fold lines 125 allow the shape of the anterior portion 100of the orthopedic device to be such, that when applied to the anatomicalportion, the anterior portion 100 has less contact with, and producesless pressure on, the sternomastoid muscle area of the neck and is thusless likely to provide pressure on the veins in the neck. This will infact decrease the possibility of vascular obstruction of blood whichneeds to drain from the brain and thus, the cervical collar according tothe present disclosure is less likely to increase intracranial pressure.

The generalized structure and musculature of the neck is shown in FIGS.12A and 12B. As shown in FIG. 12A, the sternocleidomasteoidus(sternomastoid) muscle 620 extends upwardly and posteriorly from theclavicle and sternum 262 toward the mastoid process. The mandible 622extends anteriorily away from the neck, above the sternomastoid muscle620. The trapezius muscle 624 wraps around from the back to a positionunderneath the sternomastoid muscle 620, as shown in FIGS. 12A and 12B.

As generally shown in FIG. 14, the carotid artery 111 is positionedwithin the neck, and supplies blood to the brain. The external 105 andinternal 107 jugular veins of the neck drain blood from the brain. Theexternal 105 and internal 107 jugular veins lie relatively close to thesurface of the skin, and are thus more susceptible to compression whenan external force is applied to the neck, such as, for example, by arigid cervical collar. Accordingly, the orthopedic device according tothis disclosure provides a structure for a cervical collar that allows agap to be formed between the cervical collar and the sternomastoidmuscle area of the neck.

Specifically, the shape of the orthopedic device at the anterior portion100 thereof, as shown in FIGS. 13 and 14, when applied to the neck of apatient, forms a clearance of the neck veins by way of fold lines 125 inthe anterior portion 100 of the collar.

By way of the disclosed structure of the orthopedic device, and as canbe seen in FIGS. 13 and 14, pressure applied by the orthopedic device tothe body is transferred away from the sternomastoid muscle area of theneck, and in particular, away from the external 105 and internal 107jugular veins of the neck. The pressure applied by the orthopedic deviceto the body is instead transferred to other portions of the neck. Inparticular, the pressure applied by the orthopedic device to the body istransferred to, for example, the trapezius muscle 624, the mandible 622,and the sternum 626.

In reference to FIGS. 10 and 13, the central portion of the anteriorportion 100 of the orthopedic device attaches to the sternal extensionadjustment part 130, and is relatively flat, while the curve of theanterior portion 100 of the orthopedic device provided by the fold lines125 forms a generally rounded corner which defines a gap 109 opposite tothe relatively curved surface of the neck at the location of the largecervical veins (vena jugularis externa and interna; external andinternal jugular veins) draining blood from the brain, thus, providingreduced vascular obstruction, and reducing the likelihood of an increasein intracranial pressure.

As shown in FIG. 4, the fold lines 125 are provided along a posteriorsurface of the anterior portion 100 of the orthopedic device. The foldlines 125 are generally arranged perpendicularly on either side of theopen access area 108. The fold lines 125 allow the generally rigid orsemi-rigid plastic of the orthopedic device to naturally curve into ashape that provides the appropriate clearance for the neck veins, sothat there is less vascular obstruction in order to prevent intracranialpressure buildup.

FIG. 14 illustrates the anterior 100 and posterior 148 portions of thecervical collar together in use on a patient as providing a gap 109formed at the sternomastoid muscle area of the neck so as to be lesslikely to form pressure on the external 105 and internal 107 jugularveins. As can be seen, the central portion of the anterior portion 100of the orthopedic device is relatively flat, while the curve of theanterior portion 100 of the orthopedic device provided by the fold lines125 forms a generally rounded corner which leaves a gap 109 opposite tothe relatively curved surface of the neck at the location of theexternal 105 and internal 107 jugular veins draining blood from thebrain, thus, providing reduced vascular obstruction, and reducing thelikelihood of an increase in intracranial pressure.

The height of the anterior portion 100 of the orthopedic device can beadjusted to an appropriate size via the use of the third component ofthe anterior portion 100 of the orthopedic device; the adjustable heightsupport 130. The adjustable height support 130 is configured to beremovable from the anterior portion 100, such that the cervical collarcan be removed from a patient without removing life support devices thatmay be connected to the patient in the trachea region, such as breathingand/or feeding tubes. For example, adjustable height support 130 can beremoved from the anterior portion 100 of the orthopedic device in orderto perform cleaning around or other maintenance of the breathing and/orfeeding tubes, while the rest of the orthopedic device remains in placeon the patient, or is also removed. Once maintenance is complete, theorthopedic device can be repositioned on the patient and/or theadjustable height support 130 can be reconnected to the orthopedicdevice.

As best seen in FIG. 3, the adjustable height support 130 includes twoupright leg portions 131 configured to cooperate with the dependingprojections 106. Recessed portions 140 are formed in the upright legportions 131 and have a corresponding shape to the depending projections106 for receiving the respective depending projections 106 therein toallow the adjustable height support 130 to be positioned at differentheights along the depending projections 106.

As best shown in FIGS. 1, 3, and 4, each upright leg portion 131includes a locking button 132 that can be manipulated to selectivelylock the adjustable height support 130 from being adjusted to a shorterheight. The locking buttons 132 are received in appropriately sized andshaped cut out portions of the upright leg portions 131.

As seen in FIGS. 5 and 6, each locking button 132 includes a pivot axle134, which is received in the upright leg portion 131, to allow thelocking button 132 to be pivoted thereon from an engaged, lockedposition, to a disengaged, unlocked position. At least one lockingprotrusion 138 is formed on each locking button 132. The lockingprotrusion 138 is configured to selectively engage a correspondingportion of the cut out portions of the upright leg portions 131 toselectively lock the locking button 132 in the engaged, locked positionin order to prevent accidental movement of the adjustable height support130 to a shorter height.

Teeth 136 are formed along a reduced thickness portion of the pivot axle134 for selective engagement with the locking projections or ratchets116 formed on the depending projections 106. The teeth 136 are formedsimilarly, but in opposition to, the locking projections or ratchets116, such that the teeth 136 include a first edge having a firstthickness that tapers out to a linear edged having a second thicknessthat is larger than the first thickness, wherein the linear edges of theteeth 136 engage with the linear edges of the locking projections orratchets 116 to selectively lock the adjustable height support 130 frombeing adjusted to a shorter height.

When the locking buttons 132 are pivoted to the disengaged, unlockedposition, the teeth 136 are removed from contacting the lockingprojections or ratchets 116 formed on the depending projections 106.Thus, the adjustable height support 130 can freely move either up ordown to either decrease or increase the height. In this manner, theposition of the adjustable height support 130 on the associateddepending projections 106 can be altered to accommodate differentanatomical sizes of wearers.

When the locking buttons 132 are pivoted to the engaged, lockedposition, the teeth 136 are in contact with the locking projections orratchets 116 formed on the depending projections 106, and the engagementof the linear edges of the teeth 136 and the locking projections orratchets 116 prevents the movement of the adjustable height support 130in the upward direction in order to prevent the adjustable heightsupport 130 from being adjusted to a shorter height. However, since theteeth 136 are formed on a reduced thickness portion of the pivot axle134, the adjustable height support 130 can be moved downward to beadjusted to an increased height, since the reduced thickness portion ofthe pivot axle 134 provides resiliency to the teeth 136 and allows thetapered portions of the teeth 136 to slide over the tapered portions ofthe locking projections or ratchets 116.

In this manner, the position of the adjustable height support 130 on theassociated depending projections 106 can be adjusted to increase theheight without manipulating the locking buttons 132. This feature is abenefit for quickly applying the cervical collar to a patient. Thecervical collar can be packaged with the adjustable height support 130positioned in the shortest height configuration, in order to save onpackaging space, and the locking buttons 132 positioned in the engaged,locked position. The cervical collar can be taken directly from thepackaging, and the position of the adjustable height support 130 can beincreased to accommodate different sized anatomies, simply by pullingdownward on the adjustable height support 130.

Fine tuning of the height of the cervical collar can be achieved bypivoting the locking buttons 132 to the disengaged, unlocked position,and adjusting the height of the adjustable height support 130 as needed.

In a variation, the adjustable height support 130 can be replaced with asupport that is still removable, but which is not height adjustable. Inparticular, the support may still have the locking buttons 132, whichmay engage one set of projections or ratchets 116 formed on thedepending projections 106, which projections or ratchets 116 define asingle size setting. In this manner, a collar having a specific setheight can be provided, while still allowing the collar to be removedfrom a patient without removing life support.

As shown in FIGS. 1, 3, and 4 the adjustable height support 130 includesa flared distal end that is configured to engage an anatomical portion,such as the sternum, to provide stabilization and support of the mainsupport piece 102 and the 3D anatomically configured proximal supportportion 120 with respect to the respective anatomical portions supportedthereby, for example, the neck, chin, and jaw.

A hinged distal connecting portion 142 is connected to the distal end ofthe adjustable height support 130, and includes a footpad 144 thereon.The hinge of the distal connecting portion 142 can be formed as a livinghinge, and allows the distal end of the adjustable height support 130 topivot to accommodate different sizes and shapes of anatomical portionsof patients, for example, the sternum. The footpad 144 can be anintegrally formed footpad, or a removable and/or replaceable footpadconfigured to engage an anatomical portion, such as the sternum. Toprovide comfort to the wearer and to avoid skin ulceration, the footpad144 can be a resilient or compliant pad formed, for example, byovermolding. The footpad 144 can also be formed as open or closed cellfoam padding, and/or, for example, a disposable hydrophilic foam pad.

The anterior portion 100 of the orthopedic device is configured tocooperate with a posterior portion 146 of the orthopedic device tostabilize and support an anatomical portion of a user, as discussed indetail below.

C. Detailed Description of a Posterior Portion of an Orthopedic Device

A posterior portion 146 of an orthopedic device is shown in FIGS. 7-9.The posterior portion 146 of the orthopedic device is constructed in asimilar manner as discussed above with respect to the anterior portion,and includes a main support piece 148 and anatomically configured 3Dproximal and distal support portions 168, 174.

In a similar manner as previously discussed, the posterior main supportpiece 148 includes slots 150 that provide ventilation and compliance tothe main support piece 148. The slots 150 are formed in three sectionsof the main support piece 148, the middle section and two upper sidesections. The slots 150 in the middle section progress fromsubstantially straight shapes near the center line to slightly arcuateshapes near the edges. The slots 150 in the upper side sections aregenerally arcuate shapes. The shapes of the slots 150 are specificallyconfigured to provide compliance to the main support piece 148 to allowthe posterior portion 146 to conform to different sized anatomicalportions of patients. An open cervical access area, 162 is positionedabove the middle section and between the upper side sections to provideaccess to the spine. Further, the main support piece 148 is configuredto provide a clearance of the device for the C7 vertebrae.

As with the previously described anterior main support piece, flexibleor resilient edges 154 are provided around the periphery of the mainsupport piece 146. The flexible or resilient edges 154 are increased insize from a small flexible edge along the side extending portions 152that is substantially smaller than the side extending portions 152 to ananatomically configured 3D proximal and distal support portions 168, 174that may be contiguously formed with the flexible or resilient edges 154in the proximal and distal central sections. The anatomically configured3D proximal and distal support portions 168, 174 are of a similar sizeto the middle section and two upper side sections of the main supportpiece 148. In this manner, the larger size anatomically configured 3Dproximal and distal support portions 168, 174 are able to conform to alarge variety of different sizes and shapes of anatomical portions ofdifferent users. The flexible or resilient edges 154 and theanatomically configured 3D proximal and distal support portions 168, 174can be formed, for example, by overmolding.

As best seen in FIG. 8, the proximal support portion 168 includes ananatomically shaped flared section 170 that is shaped to correspond toand support an anatomical portion of a wearer, for example, theoccipital region.

As with the anterior portion described above, as shown in FIGS. 8 and 9,orienting indicia 172 are provided on the anatomically configured 3Dproximal and distal support portions 168, 174 to indicate theappropriate positioning of the posterior portion 146 of the orthopedicdevice on the patient. The indicia 172 can be graphically symbolic,and/or alphanumeric in nature, and can be provided in any suitableposition on the posterior portion 146.

As best seen in FIG. 9, the anterior surface portion of the posteriorportion 146 includes a plurality of liner connection points 166, formedin the same manner and for the same purposes as previously discussedwith respect to liner connection points 128. Additionally, fold lines164, of the same configuration as previously discussed, are alsoprovided to allow the posterior portion 146 of the orthopedic device tobe conformed to different sizes and shapes of anatomical portions ofpatients.

In a slight variation from the anterior portion discussed above, theposterior main support piece 146 includes side extending portions 152that extend from each side and further include strap portions 156extending therefrom to aid with circumferential adjustment of theorthopedic device.

The strap portions 156 are formed generally integrally with the flexibleor resilient edges 154, and are also flexible or resilient. The strapportions 156 are connected to the side extending portions 152 at trimlines 160, which can be used to more easily remove the strap portions156 so that the orthopedic device can be used with a proper fit onpersons having a very thin anatomical portion, such as a very thin neck.

As can be seen in FIGS. 7 and 8, reduced thickness slots 158 areprovided in the strap portions 156. The reduced thickness slots 158 donot pass all the way through the strap portions 156, but still provideadditional compliance to allow the strap portions 156 to be more easilybent.

D. Use of Anterior and Posterior Portions Together

As shown in FIGS. 10, 11, and 13, the anterior and posterior portions100, 146 are used together to immobilize and stabilize an anatomicalportion of a user, such as the neck or cervical area. A two part liner176 can be provided as an interface between the patient and therespective anterior and posterior portions 100, 146.

As best seen in FIG. 10, the anterior portion 100 is first applied andconformed to the anatomy of the patient. The anterior surface portion ofthe anterior portion 100 can include integrally formed hooks or loops toform a first part of a hook and loop fastening system. Alternatively,the hooks or loops can be provided as separate pieces that are adheredto the anterior portion 100.

Once the anterior portion 100 is placed on the patient, the posteriorportion 146 can be applied. The side extending portions 152 and thestrap portions 156 are then folded over the folded portions of theanterior portion 100. Corresponding loops or hooks are similarlyintegrally formed with or connected to the strap portions 156 (and maybe provided on the side extending portions 152 also) for selectiveengagement with the hooks or loops provided on the anterior portion 100.Since the respective hook and loop fastening elements are provided alonga majority of the surfaces of the anterior and posterior portions 100,146, a wide range of circumferences of anatomical portions of patientscan be accommodated.

By way of this strap configuration, there is little to no relativevertical movement between the anterior portion 100 and the posteriorportion 146. Thus, the orthopedic device as described herein providesadditional immobilization for flexion and extension of the anatomicalportion (the neck).

E. Variation of an Orthopedic Device

A variation of a main support piece of an anterior portion 600 of anorthopedic device is shown in FIGS. 15-17.

While only the anterior portion 600 of the orthopedic device is shown,it will be recognized that a posterior portion of the orthopedic devicehaving a generally similar construction to the anterior portion 600 ofthe orthopedic device is provided in combination with the anteriorportion 600, along with suitable connection mechanisms, such as strapshaving hook and loop fasteners, to encircle the neck of a patient toprovide stabilization and support thereto in a manner that is generallyknown.

As seen in FIGS. 15 and 16, the anterior portion 600 of the orthopedicdevice has a generally semi-circular structure for partially surroundingand enclosing an anatomical portion of a patient, for example, the neck.A chin supporting structure 602 extends generally outwardly away fromthe main support piece of the anterior portion 600 of the orthopedicdevice.

As best shown in FIGS. 15 and 17, depending projections 604 are formedon each side of the anterior portion 600 of the orthopedic device, anddefine an open access area 606 therebetween, for example, to provideaccess to the trachea.

The anterior portion 600 of the orthopedic device can be constructedfrom a foam material, such as, for example, a closed cell polyethylenefoam, for example Plastazote®, which can be water jet cut, C-N-C routed,thermoformed, or pressure-formed. Of course, it will be recognized thatany suitable material may be used.

The anterior portion 600 of the orthopedic device can thus be formed asa semi-rigid foam cervical collar portion. As previously discussed, arigid or semi-rigid cervical collar can produce pressure on the externaland internal jugular veins, which may lead to an increase inintracranial pressure.

As best seen in FIG. 16, the anterior portion 600 of the orthopedicdevice includes recessed surfaces 608 formed on the posterior side ofthe depending projections 604 of the anterior portion 600 of theorthopedic device. The recessed surfaces 608 are formed so as to providea gap 610 between the anterior portion 600 of the orthopedic device andthe neck, thus providing clearance with, and producing less pressure on,the sternomastoid muscle area of the neck so as to be less likely toform pressure on the external 612 and internal 614 jugular veins in theneck, shown in relation to the carotid arteries 616 in FIG. 16.

Again, with reference to FIG. 16, the posterior surface of the anteriorportion 600 of the orthopedic device has an overall generallysemi-circular arc 618, shown in dashed line. However, the recessedsurfaces 608 are recessed, or bowed, away from the arc 618 so as to bespaced from the sternomastoid muscle area of the neck in order toprovide the gap 610. In this manner, the anterior portion 600 of theorthopedic device has a reduced chance of compressing the external 612and internal 614 jugular veins in the neck, and thus, there is a reducedchance for the buildup of intracranial pressure.

F. Conclusion

It is understood that while the disclosed embodiments are designed toaccommodate users having different sized anatomies, the size of thedisclosed embodiments and the components thereof can be adjusted so thatdifferent users having different sized anatomical portions may benefitfrom the present designs.

It is understood that while the disclosed embodiments of the orthopedicdevice are shown having discrete anterior and posterior portions, theanterior and posterior portions may be connected with each other alongone side thereof, and a single strap or circumferential adjustmentmechanism can be provided between the anterior and posterior portionsalong the other side thereof.

It will also be recognized that the overmolded edges and 3D anatomicalportions, as well as the fold lines, living hinge, and/or slotstructures, can be provided to a collar, without providing otherfeatures, such as the height adjustability, to the collar.

Of course, it is to be understood that not necessarily all objects oradvantages may be achieved in accordance with any particular embodimentof the invention. Thus, for example, those skilled in the art willrecognize that the invention may be embodied or carried out in a mannerthat achieves or optimizes one advantage or group of advantages astaught herein without necessarily achieving other objects or advantagesas may be taught or suggested herein.

The skilled artisan will recognize the interchangeability of variousdisclosed features from different embodiments. In addition to thevariations described herein, other known equivalents for each featurecan be mixed and matched by one of ordinary skill in this art toconstruct an orthopedic device in accordance with principles of thepresent invention.

Although this invention has been disclosed in the context of certainexemplary embodiments and examples, it therefore will be understood bythose skilled in the art that the present invention extends beyond thespecifically disclosed embodiments to other alternative embodimentsand/or uses of the invention and obvious modifications and equivalentsthereof. Thus, it is intended that the scope of the present inventionherein disclosed should not be limited by the particular disclosedembodiments described above.

1. A cervical collar, comprising: an anterior portion; a posteriorportion having side extending portions removably connecting to theanterior portion, the posterior portion including a rigid or semi-rigidmain support piece and a resilient edge integrally secured to at least asubstantial portion of a periphery of the main support piece that issubstantially more flexible than the main support piece.
 2. The cervicalcollar according to claim 1, wherein the resilient edge increases insize from a portion located along the side extending portions and toanatomically configured 3D proximal and distal support portions, theresilient edge being formed contiguously with the main support piece atproximal and distal central regions of the posterior portion.
 3. Thecervical collar according to claim 2, wherein the anatomicallyconfigured 3D proximal and distal support portions are of a similar sizeand shape to the central region and two proximal side regions of themain support piece.
 4. The cervical collar according to claim 2, whereinthe anatomically configured 3D proximal and distal support portionsconform and support different sizes and shapes of anatomical portions ofdifferent users.
 5. The cervical collar according to claim 2, whereinthe resilient edge is formed along the anatomically configured 3Dproximal and distal support portions as a molding located over the mainsupport piece.
 6. The cervical collar according to claim 1, wherein theproximal support portion defines anatomically shaped flared sectionsspaced apart by a concave and arcuate section of the resilient edge andshaped to correspond to and support an occipital region of a wearer ofthe collar.
 7. The cervical collar according to claim 1, wherein themain support piece defines opposed upper side sections extendingupwardly toward a proximal middle region, the opposed upper sidesections being spaced apart by a distance.
 8. The cervical collaraccording to claim 7, wherein the resilient edge extends between theopposed upper side sections of the main support piece at the proximalmiddle region.
 9. The cervical collar according to claim 7, wherein theposterior portion defines a cervical access opening positioned at acentral middle region and below the upper side sections to provideaccess to a spine of a wearer of the collar.
 10. The cervical collaraccording to claim 1, wherein portions of the main support piece arecovered by the resilient edge molded along at least one surface thereof.11. The cervical collar according to claim 10, wherein at least asegment of the periphery of the main support piece is exposed betweenportions of the resilient edge located on adjacent sides of the segment.12. The cervical collar according to claim 1, wherein an inner surfaceof the main support piece has less area covered by the resilient edgethan an outer surface of the main support piece.
 13. A cervical collar,comprising: an anterior portion; a posterior portion having sideextending portions removably connecting to the anterior portion, theposterior portion including a rigid or semi-rigid main support piece anda resilient edge integrally secured to at least a substantial portion ofa periphery of the main support piece that is substantially moreflexible than the main support piece, the main support piece definingopposed upper side sections and a lower section, the upper side sectionsextending upwardly from the side extending portions in an orientationtoward a proximal middle region and spaced apart by a first distance,and the lower section extending continuously between the side extendingportions and spaced a second distance from the upper side sections. 14.The cervical collar according to claim 13, wherein the resilient edgeextends between the opposed upper side sections of the main supportpiece at the proximal middle region.
 15. The cervical collar accordingto claim 13, wherein the posterior portion defines a cervical accessopening positioned at a central middle region and located between theupper side sections and the lower section to provide access to a spineof a wearer of the collar.
 16. The cervical collar according to claim15, wherein the resilient edge surrounds the cervical access opening.17. The cervical collar according to claim 15, wherein main supportpiece defines a plurality of through extending slots defined in anorientation according to the shape of the upper side sections and thelower section.
 18. A cervical collar, comprising: an anterior portion; aposterior portion having side extending portions removably connecting tothe anterior portion, the posterior portion including a rigid orsemi-rigid main support piece and a resilient edge integrally secured toat least a substantial portion of a periphery of the main support piecethat is substantially more flexible than the main support piece;flexible strap portions integrally secured with and extending from theside extending portions, the side extending portions formed from atleast part from the main support piece and the strap portions formedfrom the resilient edge; wherein the strap portions removably secure toan outer surface of the anterior portion.
 19. The cervical collaraccording to claim 18, wherein the strap portions extend beyond fromelongate trim lines formed adjacent the main support piece.
 20. Thecervical collar according to claim 18, wherein strap portions definereduced thickness slots that do not pass all the way through the strapportions.